Xiaflex Clinical Studies

Corporate Medical Policy - Blue Cross And Blue Shield Of ...
Clostridial collagenase histolyticum (Xiaflex™) and/or specific clinical indications for its use, please consult your physician. Policy studies with direct comparisons are not available. ... Doc Viewer

New Drug Approvals In 2010 - :: Pharma Tree::
Dainippon Sumitomo's Latuda. In four six-week studies, the drug performed better than a placebo in reducing schizophrenic symptoms. Like all other atypical antipsychotics, and initiated XIAFLEX global phase III clinical trials for Peyronie's disease," Anido says in a release. ... Fetch Full Source

BioSpecifics Technologies Corp. Investor Presentation Now Available For On-demand Viewing At RetailInvestorConferences ...
NEW YORK, Dec. 10, 2012 /PRNewswire/ -- RetailInvestorConferences.com is pleased to announce that BioSpecifics Technologies Corp.'s (NASDAQ: BSTC) December 6th RetailInvestorConferences.com presentation ... Read News

Peyronie's Disease - Wikipedia, The Free Encyclopedia
Collagenase clostridium histolyticum (marketed as Xiaflex by Auxilium), several clinical studies such as the one mentioned above point to penis extenders as a possible treatment to correct curvature, or at the very least to impede the curvature from getting worse. ... Read Article

Company Snapshot
• (See discussion of the Xiaflex phase III clinical data below) (clinical studies have demonstrated highly variable recurrence rates), we believe the cost benefit ... Fetch This Document

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES
In Xiaflex clinical studies, the primary efficacy endpoints were all measures that assessed the change in the degree of the Dupuytren’s contracture (i.e., the proportion of patients who achieved a reduction in contracture of the ... View Doc

Effective March 12, 2012 UTILIZATION MANAGEMENT STANDARD ...
CLINICAL REVIEW PREAUTHORIZATION LIST histolyticum; Xiaflex Required Required Comfort; Convenience, Cosmetic or Custodial Services or Procedures Sleep Studies Required for Medicare Advantage Required Spine Surgery Program ... Access Full Source

Remedy For Scars And Scar Removal - Alternative Medicine ...
There have been three major clinical studies in the United States, however, and none have not found that it can improve hypertrophic scars. One study found that there was no difference in redness and itchiness after one month (three times a day) of onion extract gel. ... Read Article

Dupuytren's Contracture - Wikipedia, The Free Encyclopedia
Not many studies are conducted, The treatment is marketed by Auxilium Pharmaceuticals as Xiaflex In February 2011, Most of the surgeons decide on clinical experience and personal preference whether to use a splint or not. ... Read Article

XIAFLEX For Dupuytren’s Contracture
XIAFLEX for Dupuytren’s Contracture Last Review Date: July 18, 2012 Number: MG.MM.ME.bC2 Medical Guideline Disclaimer Property of EmblemHealth. (including clinical outcome studies in the peer-reviewed published medical literature, ... View Doc

Xiaflex® (collagenase Clostridium Histolyticum) For ...
Xiaflex® (clostridial collagenase histolyticum) injection meets Blue Cross and Blue Shield of Ongoing Clinical Trials Several studies were identified on injectable clostridial collagenase injections in a search of the ... View Full Source

A Patient’s Guide
XIAFLEX® is for adult patients with Dupuytren’s contracture when a cord can be felt. Signs to look for What happens when the cord tightens? 2 *In clinical studies, 44% to 64% of patients receiving XIAFLEX® (versus 5% to 7% of patients receiving ... Retrieve Content

National Medical Policy - Health Net
Xiaflex (clostridial collagenase histolyticum) for the Treatment of Dupuytren's The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, ... Retrieve Doc

Www.pbm.va.gov
Physicians must complete the XIAFLEX Xperience™ training and enrollment process before their healthcare facility may receive CCH orders. Pivotal Clinical Trials (Studies 57 and 59) Inclusion/Exclusion Criteria Treatment Demographics/Baseline Characteristics Results Hurst 2009. R, DB, PC. ... Fetch Document

DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver Spring, MD 20993
Holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes if FDA makes certain findings required by the statute Xiaflex injections each patient received, the reported signs and symptoms of systemic allergic ... View Document

Collagenase Clostridium Histolyticum - Wikipedia, The Free ...
Clinical data; Pregnancy cat. B No interaction studies have been conducted because the drug does not reach the bloodstream and the liver. It is theorised that drugs interfering with matrix metalloproteinases, such as tetracyclines, ... Read Article

6 ADVERSE REACTIONS
Clinical studies in endometriosis suggest the addition of Hormone Replacement Therapy (estrogens and/or progestins) to ZOLADEX may decrease the occurrence of vasomotor symptoms and vaginal dryness associated with hypoestrogenism without compromising the ... Access Full Source

E-A LERT Food & Drug - Covington & Burling LLP
In Xiaflex clinical studies, the primary efficacy endpoints were all measures that assessed the change in the degree of contracture. Although Xiaflex treatment demonstrated a reduction in contracture of the selected primary joint in a greater proportion of ... Fetch Full Source

20120224 XIAFLEX Prescribing Information Final
Clinical studies of another drug and may not reflect the rates observed in practice. Out of 1082 patients who received 0.58 mg of XIAFLEX in the controlled and uncontrolled portions of the XIAFLEX studies (2630 XIAFLEX injections), 3 (0.3%) ... Retrieve Here

FDA Perspective Xiaflex - U S Food And Drug Administration ...
Contracture Recurrence in Xiaflex Studies vs. Recurrence in Surgery Literature. 10. Subgroup Analysis by Expertise of Investigator Who Performed Injections. 1. 1. Primary efficacy endpoint In non-clinical studies response resolves ... Fetch Content

With Botulinum Toxin Effects. These Symptoms Have Been ...
14 CLINICAL STUDIES 14.1 Cervical Dystonia 14.2 Blepharospasm 14.3 Glabellar Lines 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 16.3 Handling 17 PATIENT COUNSELING INFORMATION 17.1 General ... Document Viewer

1-888-566-0008, 1-800-900-1451, Www.bmchp
BMC HealthNet Plan – Xiaflex 1 of 3 1-888-566-0008, 1-800-900-1451, www.bmchp.org conclusions based upon the regulatory status of the technology and a review of clinical studies published in peer-reviewed medical literature. ... Retrieve Document

Cigna Medical Coverage Policy - Cigna, A Global Health ...
Clinical studies provide some evidence to support the effectiveness of Page 8 of 23 Coverage Policy Number: 0024. acupuncture for the treatment of chronic headaches, low back and neck pain and osteoarthritis of the knee. ... Retrieve Doc